Dataset Information

Real-World Experience With Collagenase Clostridium Histolyticum-aaes for Buttock and Thigh Cellulite: Focus on Administration and Safety Profile.

ABSTRACT:

Background

Collagenase clostridium histolyticum-aaes (CCH-aaes) is approved for the treatment of moderate-to-severe buttock cellulite in adult women.

Objectives

To report on real-world experience with CCH-aaes in the treatment of buttock and thigh cellulite.

Methods

Retrospective analysis of medical records from a single treatment center.

Results

The population comprised 28 consecutively treated women; mean age was 40.5 years (range, 23-56 years) and mean body mass index was 25.9 kg/m² (range, 19.6-41.0 kg/m²). Treatment areas were buttocks only (78.6% of patients), thighs only (10.7%), or both buttocks and thighs (10.7%). Most patients (89.3%) were treated in 2 areas (buttocks or thighs) at each visit; however, 3 patients were treated in 4 areas. At each session, the CCH-aaes dose was 0.07 mg per dimple (0.3 mL of 0.23 mg/mL for buttock cellulite; 1.5 mL of 0.046 mg/mL for thigh cellulite). The mean number of treatment sessions was 2.6 (range, 1-4) for buttock cellulite and 2.5 (range 1-3) for thigh cellulite. The mean number of dimples treated was 11.5 (range, 3-17) per buttock, 11.0 (range, 1-14) per thigh, and 23.4 (range, 8-32) overall per treatment session. Injection site-related adverse events of special interest were experienced by all 28 patients: bruising (100%), edema (96.4%), tenderness (85.7%), nodules (39.3%), pruritus (32.1%), and hyperpigmentation indicative of hemosiderin staining (7.1%). Mean duration of injection-site bruising was 8.8 days (range, 2-15 days).

Conclusions

CCH-aaes is an effective, well-tolerated, minimally invasive treatment option for buttock and thigh cellulite in women.

Level of evidence 3

SUBMITTER: Shridharani SM

PROVIDER: S-EPMC10108883 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

Real-World Experience With Collagenase Clostridium Histolyticum-aaes for Buttock and Thigh Cellulite: Focus on Administration and Safety Profile.

Shridharani Sachin M SM Kennedy MacKenzie L ML

Aesthetic surgery journal. Open forum 20230220

<h4>Background</h4>Collagenase clostridium histolyticum-aaes (CCH-aaes) is approved for the treatment of moderate-to-severe buttock cellulite in adult women.<h4>Objectives</h4>To report on real-world experience with CCH-aaes in the treatment of buttock and thigh cellulite.<h4>Methods</h4>Retrospective analysis of medical records from a single treatment center.<h4>Results</h4>The population comprised 28 consecutively treated women; mean age was 40.5 years (range, 23-56 years) and mean body mass i ...[more]

PMID: 37077934

Similar Datasets

Project description:BackgroundCollagen-rich fibrous septae and subcutaneous adipose protrusions play a role in cellulite pathophysiology. Collagenase clostridium histolyticum-aaes (CCH-aaes) injection causes enzymatic release of septae to resolve cellulite depressions and create a skin smoothing effect. This analysis pooled data from two identically designed, phase-3, randomized, double-blind, placebo-controlled studies to examine the efficacy and safety of CCH-aaes.MethodsAdult women with moderate/severe cellulite (3-4 on Clinician Reported Photonumeric Cellulite Severity Scale and Patient Reported Photonumeric Cellulite Severity Scale) on the buttocks received up to three treatment sessions (Days 1, 22, and 43) of subcutaneous CCH-aaes 0.84 mg or placebo per treatment area. Composite and individual component response (≥2-level or ≥1-level improvement from baseline in Patient Reported Photonumeric Cellulite Severity Scale and/or Clinician Reported Photonumeric Cellulite Severity Scale) and additional patient-reported outcomes were determined at Day 71.ResultsAnalysis included 424 CCH-aaes-treated and 419 placebo-treated women. CCH-aaes-treated women were 5.9 times more likely than placebo-treated women to be ≥2-level composite responders at Day 71 (odds ratio [95% confidence interval], 5.9 [2.2-15.4]; P < 0.001). A significantly greater percentage of CCH-aaes-treated women versus placebo-treated women were ≥1-level composite responders at Day 71 (39.4% versus 14.6%; P < 0.001). Subgroup analyses indicated no apparent impact of Fitzpatrick skin type category and baseline cellulite severity (moderate/severe) on CCH-aaes efficacy. An inverse relationship between age and CCH-aaes response was observed in those with a body mass index less than 32 kg per m2. The most common adverse events with CCH-aaes were injection-site bruising and injection-site pain.ConclusionCCH-aaes treatment significantly improved moderate-to-severe buttock cellulite appearance and was generally well tolerated.

Project description:BackgroundTo determine the safety and efficacy of collagenase clostridium histolyticum (CCH) injection for the treatment of palmar Dupuytren disease nodules.MethodsIn this 8-week, double-blind trial, palpable palmar nodules on one hand of adults with Dupuytren disease were selected for treatment. Patients were randomly assigned using an interactive web response system to receive a dose of 0.25 mg, 0.40 mg, or 0.60 mg (1:1:1 ratio) and then allocated to active treatment (CCH) or placebo (4:1 ratio). All patients and investigators were blinded to treatment. One injection was made in the selected nodule on Day 1. Caliper measurements of nodule length and width were performed at screening and at Weeks 4 and 8. Investigator-reported nodular consistency and hardness were evaluated at baseline and Weeks 1, 4, and 8. Investigator-rated patient improvement (1 [very much improved] to 7 [very much worse]) and patient satisfaction were assessed at study end.ResultsIn the efficacy population (n = 74), percentage changes in area were significantly greater with CCH 0.40 mg (-80.1%, P = 0.0002) and CCH 0.60 mg (-78.2%, P = 0.0003), but not CCH 0.25 mg (-58.3%, P = 0.079), versus placebo (-42.2%) at post-treatment Week 8. Mean change in nodular consistency and hardness were significantly improved with CCH versus placebo at Weeks 4 and 8 (P ≤ 0.0139 for all). At Week 8, investigator global assessment of improvement was significantly greater with CCH 0.40 mg and 0.60 mg (P ≤ 0.0014) but not statistically significant with CCH 0.25 mg versus placebo (P = 0.13). Most patients were "very satisfied" or "quite satisfied" with CCH 0.40 mg and 0.60 mg. Contusion/bruising (50.0% to 59.1%) was the most common adverse event with CCH treatment.ConclusionIn patients with Dupuytren disease, a single CCH injection significantly improved palmar nodule size and hardness. The safety of CCH was similar to that observed previously in patients with Dupuytren contracture.Trial registrationClinicalTrials.gov identifier: NCT02193828 . Date of trial registration: July 2, 2014 to December 5, 2014.

Dataset Information

Real-World Experience With Collagenase Clostridium Histolyticum-aaes for Buttock and Thigh Cellulite: Focus on Administration and Safety Profile.

Background

Objectives

Methods

Results

Conclusions

Level of evidence 3

Publications

Real-World Experience With Collagenase Clostridium Histolyticum-aaes for Buttock and Thigh Cellulite: Focus on Administration and Safety Profile.

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